the range on average 91% of the total radioactivity was recovered in feces. Less than 1% of the administered dose was recovered in urine. Unchanged simeprevir in feces accounted for on average 31% of the administered dose. The terminal elimination half-life of simeprevir was 10 to 13 hours in HCV-uninfected subjects and 41 hours in HCV-infected subjects receiving 200 mg (1.3 times the recommended dosage) of simeprevir. Specific Populations Geriatric Use There is limited data on the use of Olysio in patients aged 65 years and older. Age (18 73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV-infected subjects treated with Olysio [see Use in Specific Populations (8.5) ] . Renal Impairment Compared to HCV-uninfected subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR greater than or equal to 80 mL/min) the mean steady-state AUC of simeprevir was 62% higher in HCV-uninfected subjects with severe renal impairment (eGFR below 30 mL/min). In a population pharmacokinetic analysis of mild or moderate renally impaired HCV-infected subjects treated with Olysio 150 mg once daily customize
parent liary excretion. Renal clearance plays an insignificant role in its elimination. Following a single oral administration of 200 mg 14 C-simeprevir to healthy subjects conflict
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